Shire acts against Sandoz and Amneal

Shire is taking legal action against Amneal and Sandoz for patent infringements

Shire has filed lawsuits in the US District Court for the District of New Jersey against each of Amneal Pharmaceuticals and Sandoz for infringement of Shire's VYVANSE patents.

The lawsuits were initiated in response to abbreviated new drug applications filed by Amneal and Sandoz seeking US Food and Drug Administration (FDA) approval to market and sell generic versions of all currently approved doses of VYVANSE.

Under the Hatch-Waxman Act, the FDA must refrain from approving the Sandoz and Amneal ANDAs for 30 months (expiring August 23, 2014), or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.

Sandoz declined to comment, while Amneal was unavailable to comment at the time of writing.